Recall Z-0311-2011 ยท HAW Neurological Stereotaxic Instrument
FHC, Inc.
microTargeting Drive System with Mounted Accessories Catalog numbers : 66-ZD-MD-01, MT-DS-01, FC1006 (Medtronic) Product is the FHC DBS Depth Stop Adapter, a component of the microTargeting Drive and the STar Drive. The Drives are intended to be used with commercially available stereotactic systems for neurosurgical procedures which require the accurate positioning of microelectrodes, stimulating
| Date | Nov 3, 2010 (initiated Mar 30, 2010) |
| Status | Terminated |
| Reason | Fixation thumbscrew on the DBS depth stop adapter may be overtightened and damage the implantable lead. |
| Root cause | Device Design |
| Action | FHC issued an "URGENT: MEDICAL DEVICE CORRECTION" letter dated March 29, 2010, to all customers. The letter described the product, problem and actions to be taken by the customers. FHC informed the customers that that they had returned to the original design of the fixation screw in the Depth Stop Adapter. FHC sent replacement Depth Stop Adapter with an original fixation screw. The customers were instructed to discard the recalled Depth Stop Adapter (s) and replace with the enclosed corrected version(s) and sign and fax the receipt notification to 207-666-8309 as proof of their receipt of no |
| Quantity | 18 units |
| Distribution | Worldwide distribution: USA in the states of AZ, CA, FL, ID, NC, MA, MI, MN, NV, RI, UT, VA, and WA, and countries of Columbia and South Africa. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K003776 | MICROTARGETING DRIVE SYSTEM FHC, Inc., Feb 23, 2001 |